Catalog Number 110024773 |
Device Problem
Difficult or Delayed Activation (2577)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/15/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).G2: foreign- japan customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded as biohazard by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
It was reported during the surgery that the anchor of the device could not be pushed out.No adverse event has been reported as a result of the malfunction.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device is used for treatment.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information is available at the time of this report.
|
|
Search Alerts/Recalls
|